Method for coupling soft tissue to a bone

ABSTRACT

A method for coupling tissue with a flexible member including a tail and a self-locking construct coupled to the tail. The self-locking construct includes an adjustable first loop and an adjustable second loop coupled thereto. The method includes implanting an anchor in bone, the anchor slidably mounted to the tail. The tail is positioned relative to the tissue. An end of the tail is inserted through the first loop. The tail is passed through the first loop, the second loop is pulled into the anchor, and the self-locking construct is positioned relative to the tissue. The self-locking construct is tightened against the tissue by pulling on an end of the self-locking construct. The first loop is tightened onto the second loop.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 13/757,003, now U.S. Pat. No. 9,357,992, and Ser. No.13/757,019, now U.S. Pat. No. 9,314,241, each of which were filed onFeb. 1, 2013, and each of which are continuation-in-part applications ofU.S. patent application Ser. No. 13/293,825, now U.S. Pat. No.9,149,267, filed on Nov. 10, 2011. The entire disclosures of theseapplications are incorporated herein by reference.

FIELD

The present disclosure relates to apparatuses for coupling a firsttissue to a second tissue, such as coupling soft tissue to bone andmethods for coupling two portions of soft tissue together.

BACKGROUND

This section provides background information related to the presentdisclosure, which is not necessarily prior art.

Arthroscopic procedures often include sutures and anchors to secure softtissue to bone, and to secure separated portions of soft tissuetogether. Despite their widespread use, sutures and suture anchors, aswell as methods for their use, can be improved. For example, tyingsutures into knots may be very time consuming and difficult to perform,particularly inside the joint space. As a result, the cost of theprocedure may be increased and the capacity of the surgeon may belimited. Furthermore, the strength of the repair may be limited by thestrength of the knot. The methods and apparatuses disclosed hereinaddress these issues and numerous others.

SUMMARY

This section provides a general summary of the disclosure, and is not acomprehensive disclosure of its full scope or all of its features.

The present teachings provide for a method for coupling tissue with aflexible member including a tail and a self-locking construct coupled tothe tail. The self-locking construct includes an adjustable first loopand an adjustable second loop coupled thereto. The method includesimplanting an anchor in bone, the anchor slidably mounted to the tail.The tail is positioned relative to the tissue. An end of the tail isinserted through the first loop. The tail is passed through the firstloop, the second loop is pulled into the anchor, and the self-lockingconstruct is positioned relative to the tissue. The self-lockingconstruct is tightened against the tissue by pulling on an end of theself-locking construct. The first loop is tightened onto the secondloop.

The present teaching further provide for a method for coupling tissuewith a flexible member including a tail and a self-locking constructcoupled to the tail, the self-locking construct including an adjustablefirst loop and an adjustable second loop coupled thereto. The methodincludes the following: implanting an anchor in bone, the anchorslidably mounted to the tail and supported at a distal end of a rodextending from a handle of an insertion tool; decoupling a retentionmember from the handle to release the tail from being retained betweenthe handle and the retention member; passing the tail through a flexibleloop mounted to the retention member, the flexible loop extending outfrom within a plunger of the retention member, the plunger extendingthrough the first loop, the first loop coupled to a support flange ofthe retention member; pushing the first loop off the support flange byactuating the plunger; moving the first loop onto the tail; pulling thetail through the first loop; and tightening the self-locking constructagainst the tissue by pulling on an end of the self-locking construct.

The present teachings also provide for a method for coupling tissue witha flexible member including a tail and a self-locking construct coupledto the tail, the self-locking construct including an adjustable firstloop and an adjustable second loop coupled thereto. The method includesimplanting an anchor in bone, the anchor slidably mounted to the tailand supported at a distal end of a rod extending from a handle of aninsertion tool; decoupling a retention member from the handle to releasethe tail from being retained between the handle and the retentionmember; passing the tail through a flexible loop mounted to theretention member, the flexible loop extending out from within a plungerof the retention member, the plunger extending through the first loop,the first loop coupled to a support flange of the retention member;pushing the first loop off the support flange by actuating the plunger;moving the first loop onto the tail; pulling the tail through the firstloop; and tightening the self-locking construct against the tissue bypulling on an end of the self-locking construct.

Further areas of applicability will become apparent from the descriptionprovided herein. The description and specific examples in this summaryare intended for purposes of illustration only and are not intended tolimit the scope of the present disclosure.

DRAWINGS

The drawings described herein are for illustrative purposes only ofselected embodiments and not all possible implementations, and are notintended to limit the scope of the present disclosure.

FIG. 1A illustrates a knotless suture anchor device according to thepresent teachings;

FIG. 1B is a close-up view of a suture construct of the knotless sutureanchor device of FIG. 1A;

FIG. 1C illustrates another knotless suture anchor device according tothe present teachings;

FIG. 2 illustrates the knotless suture anchor device of FIG. 1Aimplanted in bone;

FIG. 3 illustrates a suture rail of the knotless suture anchor device ofFIG. 1A passed around tissue;

FIG. 4 illustrates the suture tail being passed through a first sutureloop of the suture construct of the knotless suture anchor device ofFIG. 1A;

FIG. 5 illustrates the suture construct after it has been pulled througha soft anchor of the knotless suture anchor device of FIG. 1 to surroundthe tissue;

FIG. 6 illustrates the suture construct tightened around the tissue;

FIG. 7A illustrates the knotless suture anchor device of FIG. 1Aimplanted in bone and including a second soft anchor, the deviceimplanted through tissue to secure the tissue to bone;

FIG. 7B illustrates the suture tail being passed through the firstsuture loop;

FIG. 7C illustrates the suture construct tightened against the tissue tosecure the tissue to bone;

FIGS. 8A-8D illustrate another method for coupling tissue to bone usingthe knotless suture anchor device of FIG. 1A;

FIG. 9 illustrates an additional arrangement of the knotless sutureanchor device of FIG. 1A for coupling tissue to bone;

FIG. 10 illustrates yet another arrangement of the knotless sutureanchor device of FIG. 1A for coupling tissue to bone;

FIGS. 11A-11E illustrate yet another method for coupling tissue to boneusing the knotless suture anchor device of FIG. 1A;

FIG. 12 illustrates a further arrangement of the knotless suture anchordevice of FIG. 1A for coupling tissue to bone;

FIGS. 13A-13D illustrate a method for coupling two separated tissueportions using the knotless suture anchor device of FIG. 1A;

FIG. 14 is a perspective view of an insertion device according to thepresent teachings;

FIG. 15 is a perspective view of a handle and a suture retentionassembly of the insertion device of FIG. 14;

FIG. 16 is a cross-sectional view of the handle of the insertion deviceof FIG. 14 taken along line 16-16 of FIG. 14;

FIG. 17A is a cross-sectional view taken along line 17A-17A of FIG. 14of the suture retention assembly of the insertion device of FIG. 14 in afirst position;

FIG. 17B is a cross-sectional view of the suture retention assembly in asecond position;

FIGS. 18-23 illustrate a method of using the insertion device of FIG. 14to secure tissue to bone with the knotless suture anchor device;

FIG. 24 is a perspective view of another suture retention assembly forthe insertion device of FIG. 14;

FIG. 25 is a perspective view of another insertion device according tothe present teachings;

FIG. 26 is a perspective view of a handle of the insertion tool of FIG.25;

FIG. 27 is side view of the handle of the insertion tool of FIG. 25;

FIG. 28 is a perspective view of another insertion device according tothe present teachings;

FIG. 29 is a perspective view of a handle of the insertion device ofFIG. 28;

FIG. 30 is another perspective view of the handle of the insertiondevice of FIG. 28;

FIG. 31 is a perspective view of the handle of the insertion device ofFIG. 28 showing a pin being withdrawn from the handle;

FIG. 32 illustrates the suture tail being passed through the firstsuture loop of the suture construct with the pin of FIG. 31;

FIGS. 33-38 illustrate a method of repairing torn labrum tissue usingthe knotless suture anchor device of FIG. 1;

FIG. 39 is a perspective view of another insertion device according tothe present teachings;

FIG. 40 is an exploded view of the insertion device of FIG. 39;

FIG. 41 is a perspective view of the insertion device of FIG. 39 with asuture retention assembly separated from a handle of the insertiondevice;

FIG. 42 is a perspective view of the suture retention assembly with asuture construct mounted thereto;

FIGS. 43 and 44 illustrate passage of a tail of the suture constructthrough a loop of the suture construct using the suture retentionassembly;

FIGS. 45-53 illustrate formation of a tail of a knotless suture anchordevice according to the present teachings; and

FIGS. 54-61 illustrate formation of a suture construct of a knotlesssuture anchor according to the present teachings, and coupling of thesuture construct to the tail.

Corresponding reference numerals indicate corresponding parts throughoutthe several views of the drawings.

DETAILED DESCRIPTION

Example embodiments will now be described more fully with reference tothe accompanying drawings.

With initial reference to FIG. 1A, a knotless suture anchor device, orassembly, or system is generally illustrated at reference numeral 10.The device generally includes a suture tail 12 and a suture construct 14connected thereto. The suture tail 12 and the suture construct 14 can bemade of any suitable flexible material or member, and need not be madeof a suture. The suture tail 12 and the suture construct 14 can be madeof the same or different materials. When the suture tail 12 and/or thesuture construct 14 are made of sutures, any suitable suture can beused. For example, a braided hollow-core suture can be used. The braidedsuture can include a first end and a second end with an outer wall thatdefines a passage therethrough. Any suitable braided suture can be used,such as any of the braided sutures disclosed in U.S. patent applicationSer. No. 12/915,962 ('962 Application) titled Method and Apparatus forSecuring Soft Tissue to Bone, which was filed on Oct. 29, 2010,published as Publication No. 2011/0098727 on Apr. 28, 2011, and isassigned to Biomet Sports Medicine, LLC. The disclosure of the '962application is incorporated herein by reference. To help distinguishbetween the suture tail 12 and the suture construct 14, which can beparticularly helpful for a surgeon during surgery, the suture tail 12and the suture construct 14 can be provide with different colors ordesigns, for example.

The suture tail 12 generally includes a first end 16 and a second end18, which is opposite to the first end 16. The suture tail 12 can be anysuitable length, such as about 30 inches. The suture tail 12 defines asuture tail sleeve portion 20 proximate to the second end 18 of thesuture tail 12. While the suture tail sleeve portion 20 is illustratedas being proximate to the second end 18, it may alternatively beproximate to the first end 16 or at any suitable position therebetween.The suture tail sleeve portion 20 defines an elongated passageway 22extending along at least a portion of the suture tail 12. If the suturetail 12 is a braided hollow-core suture, the passageway 22 can extendfrom the first end 16 to the second end 18 of the suture tail 12. Thepassageway 22 exits through an outer wall of the suture tail 12 at afirst opening 24 and a second opening 26 at opposite ends of thepassageway 22. The second opening 26 is closer to the second end 18 ofthe suture tail 12 than the first opening 24 is. The second opening 26is spaced apart from the second end 18. The suture construct 14 extendsthrough the suture tail sleeve portion 20 to connect the sutureconstruct 14 to the suture tail 12. The portion of the suture tail 12defining the suture tail sleeve portion 20 and the portions of thesuture tail 12 proximate to either end thereof define a locking memberor portion 28 of the suture tail 12, as further described herein.

The suture tail 12 can include a soft or flexible anchor 30 at anysuitable position between the first end 16 and the second end 18, suchas about halfway between the first end 16 and the second end 18. Theanchor 30 can be an elongate member having a sleeve or tubularconfiguration with a first anchor end 32 and a second anchor end 34 atopposite ends thereof. An internal passage 40 is defined by a wall ofthe anchor 30 and extends between the first anchor end 32 and the secondanchor end 34. The anchor 30 can be made of resorbable or non-resorbablematerials, including braided suture, sponges and sponge-like materials,including braided suture, sponges and sponge-like materials in solidform, perforated materials, woven/braided from biocompatible materialsor fibers, such as, for example, polymer, polyester, polyethylene,cotton, silk, or other natural or synthetic materials.

The anchor 30 can have any properties that allow the anchor 30 to changeshape. In this regard, the anchor 30 can be, for example, complaint,flexible, foldable, squashable, squeezable, deformable, limp, flaccid,elastic, low-modulus, soft, spongy or perforated, or have any othercharacteristic property that allows it to change shape. In some aspects,the anchor 30 can be coated with biological or biocompatible coatingsand also can be soaked in platelets and other biologics, which can beeasily absorbed by the flexible anchor 30. In an exemplaryconfiguration, the anchor 30 can be formed from a strand of No. 5braided polyester suture. In other words, multiple fibers can be braidedtogether to form a hollow braided suture having a longitudinal passage.

The anchor 30 includes a first opening 36 and a second opening 38defined in the wall of the anchor 30. The first opening 36 is proximateto, but spaced apart from, the first anchor end 32. The second opening38 is proximate to, but spaced apart from, the second anchor end 34. Thesuture tail 12 can be can be passed through the second opening 38,guided into and along the internal passage 40, and passed out of theinternal passage 40 through the first opening 36. The first and thesecond openings 36 and 38 can be apertures or voids in the woven fabricof the anchor 30, such that the first and the second openings 36 and 38do not disrupt or break the weave of the anchor 30 between the first andthe second anchor ends 32 and 34 and the corresponding first and secondopenings 36 and 38 can define anchoring leg or tail portions 42 that canprovide additional resistance for securing the anchor 30 relative to thebone.

In one exemplary configuration, the suture tail 12 can pass only throughthe first and second openings 36 and 38 and a portion of the internalpassage 40 extending therebetween to form a loop that does not extendthrough the first or the second anchor ends 32 and 34. In anotherexemplary configuration, the suture tail 12 can extend into the secondanchor end 34, through the internal passage 40, and out the first anchorend 32. In such a configuration, the anchor 30 need not include thefirst opening 36 or the second opening 38. This configuration isdescribed in U.S. application Ser. No. 13/485,304 filed May 31, 2012 andassigned to Biomet Sports Medicine, LLC of Warsaw, Ind., which isincorporated herein by reference and referred to herein as the '304Application. The anchor 30 can be any of the anchors disclosed in the'304 Application. For example, the anchors of FIGS. 20 and 21 of the'304 Application can be used when it is desirable to add additionalflexible anchors

In addition to the anchor 30, one or more additional anchors, identicalto or substantially similar to the anchor 30, can be mounted to thesuture tail 12. The device 10 can be provided with additional anchorsmounted to the suture tail 12, and/or additional anchors can be added tothe suture tail 12 during the surgical procedure. For example, a healthcare professional can add additional anchors to the suture tail 12. Theadditional anchors can be added in any suitable manner, such as by usingany one of the anchor reload devices disclosed in the '304 Application.

While FIG. 1A illustrates a single suture tail 12 connected to theanchor 30, one or more suture tails 12 each with a separate sutureconstruct 14 can be connected to the anchor 30. The additional suturetail(s) 12 can extend through the internal passage 40 or through anadditional anchor sleeve defined by the first anchor 30. For example andas illustrated in FIG. 1C, a second suture tail 12A can be seated in theinternal passage 40 and thereby connected to the anchor 30. Connected tothe second suture tail 12A is a second suture construct 14A. The secondsuture tail 12A and the second suture construct 14A can be substantiallysimilar to, or identical to, the suture tail 12 and the suture construct14 respectively. The suture tail 12 and the suture construct 14 can thusbe a first suture tail 12 and a first suture construct 14.

The suture construct 14 is a self-locking suture construct including abraided suture. The suture construct generally includes a firstadjustable suture loop 50, a second adjustable suture loop 52, a firstsuture construct body 54, and a second suture construct body 56. Thefirst adjustable suture loop 50 can be non-adjustable as well. A firstend 58 of the suture construct 14 is opposite to a second end 60 of thesuture construct 14. With particular reference to FIG. 1B, the firstbody 54 defines a first passage portion 62. The second body 56 defines asecond passage portion 64. The first passage portion 62 defines a firstpair of apertures 80 a and 80 b at opposite ends thereof through a wallof suture construct 14. The second passage portion 64 defines a secondpair of apertures 82 a and 82 b at opposite ends thereof through thewall of the suture construct 14. While the first and the second passageportions 62 and 64 each have two openings 80 a/80 b and 82 a/82 brespectively, the first and the second passage portions 62 and 64 canhave additional openings and/or can include additional passage portions.

The first body 54 is formed proximate to the first end 58 of the sutureconstruct 14. A portion of the suture construct 14 between the secondbody 56 and the first end 58 is passed through the first pair ofapertures 80 a and 80 b of the first passage portion 62 to define thefirst adjustable suture loop or noose 50. The size of the firstadjustable suture loop 50 can be adjusted by sliding the first end 58 ofthe suture construct 14 along the first adjustable suture loop 50. Forexample, the first adjustable suture loop 50 can be closed (madesmaller) by sliding the first end away from the second body 56.

Tension in the first adjustable suture loop 50 can cause the first body54 defining the first passage portion 62 to be placed in tension andtherefore cause first passage portion 62 to constrict about portion 84passed therethrough. This constriction reduces the diameter of the firstpassage portion 62, thus forming a mechanical interface between exteriorsurfaces of portion 84 and an interior surface of the first passageportion 62. This constriction results in static friction between theinterior and exterior surfaces at the mechanical interface, causing thefirst adjustable suture loop 50 to “automatically” lock in a reducedsize or diameter configuration in which tension is maintained withoutuse of a knot. This can be used to secure the first adjustable sutureloop 50 to the second adjustable suture loop 52, as described herein.

The second end 60 of the suture construct 14 is passed through the firstand the second openings 82 a and 82 b of the second passage portion 64to define the second adjustable suture loop 52. The size of the secondadjustable suture loop 52 can be adjusted by moving the second end 60 ofthe suture construct 14. For example, the second adjustable suture loop52 can be closed (made smaller) by pulling on the second end 60. Aportion of the suture construct 14 defining the second adjustable sutureloop 52 extends through the suture tail sleeve portion 20, and isslidably received in the suture tail sleeve portion 20 to connect thesuture construct 14 to the suture tail 12.

The pulling or tensioning of the first end 16 of the suture tail 12 cancause reciprocal movement of portion 86 relative to the second passageportion 64 and the second adjustable suture loop 52 can be reduced to adesired size and placed in a desired tension. Tension in the secondadjustable suture loop 52 can cause the second body 56 defining thesecond passage portion 64 to be placed in tension and therefore causesecond passage portion 64 to constrict about portion 86 passedtherethrough. This constriction reduces the diameter of the secondpassage portion 64, thus forming a mechanical interface between exteriorsurfaces of portion 86 and an interior surface of the second passageportion 64. This constriction results in static friction between theinterior and exterior surfaces at the mechanical interlace, causing thesecond adjustable suture loop 52 to “automatically” lock in a reducedsize or diameter configuration in which tension is maintained withoutuse of a knot. This can be used to secure a labral tear, a rotator cufftear, and/or in any other suitable procedure. Any other suitablesell-locking suture construct configuration can be included as well,such as any of those disclosed in the '962 Application.

With additional reference to FIG. 2, a method for implanting theknotless suture anchor device 10 in a bone 102 to secure a tissue 104 tothe bone 102 will now be described. As illustrated, the bone 102includes a hard, outer cortical bone layer 106 and a softer, innercancellous bone layer 108. The bone 102 and tissue 104 can be anysuitable bone and tissue. For example and as further described herein,the knotless suture anchor device 10 can be used to secure a tornrotator cuff or labrum in place.

As illustrated in FIG. 2, a bone hole 110 is formed in the bone 102using any suitable device, such as a surgical drill. The bone hole 110is formed proximate to the tissue 104 to be secured to the bone 102. Theanchor 30 is inserted into the bone hole 110 and positioned such thatthe first anchor end 32 and the second anchor end 34 abut anundersurface 112 of the cortical bone layer 106 at opposite sides of thebone hole 110, which restricts the suture tail 12 from being pulled outfrom within the bone 102. The anchor 30 can be inserted using anysuitable inserter, such as those described herein. The '962 Application,which is incorporated by reference, provides additional disclosure forforming a bone hole and implanting a flexible anchor. The additionaldisclosure of the '962 Application also applies to the forming of bonehole 110 and insertion of anchor 30 within the bone hole 110.

With additional reference to FIG. 3, the first end 16 of the suture tail12 is passed around and/or through the tissue 104 such that the tissue104 is between a first portion 66 and a second portion 68 of the suturetail 12. The first portion 66 is between the first end 16 and the anchor30. The second portion 68 is between the second end 18 and the anchor30.

With additional reference to FIGS. 4 and 5, the first end 16 of thesuture tail 12 is inserted through the first adjustable suture loop 50.The entire suture tail 12 is pulled through the first adjustable sutureloop 50 and the entire suture tail 12 is pulled through the internalpassage 40. Pulling the entire suture tail 12 through the internalpassage 40 causes the suture construct 14 to be pulled into the internalpassage 40 such that the second adjustable suture loop 52 extendsthrough the internal passage 40. The internal passage 40 is thusdimensioned large enough to permit passage of both the suture tail 12and the second adjustable suture loop 52. As illustrated in FIG. 5, thetissue 104 is encompassed entirely by the suture construct 14 and thesecond adjustable suture loop 52 extends through the first adjustablesuture loop 50. The internal passage 40 is also dimensioned large enoughto permit slidable adjustment of the suture construct 14 through theinternal passage 40.

With continued reference to FIG. 5 and additional reference to FIG. 6,the second end 60 of the suture construct 14 is pulled to tighten thesuture construct 14 around the tissue 104 and retain the tissue 104against the bone 102 at any suitable tension. As described above, thesecond adjustable suture loop is self-locking, and thereby secures thetissue 101 without the need for tying a knot. To further secure thesuture construct 14 around the tissue 104, the first end 58 of thesuture construct 14 is slid away from the second body 56, which closesand tightens the first adjustable suture loop 50 onto the secondadjustable suture loop 52 and provides further control over tensionapplied to the tissue 104. Further pulling of the second end 60 of thesuture construct 14 draws the locking member 28 of the suture tail 12against the first adjustable suture loop 50 to provide the lockingmember 28 with the locked configuration illustrated in FIG. 6. The firstadjustable suture loop 50 and the second adjustable suture loop 52surround the tissue 104, thereby defining a suture capture region of thedevice 10. As described above, the first adjustable suture loop isself-locking. Thus, the first adjustable suture loop 50 can be lockedonto the second adjustable suture loop 52 without the need to tie aknot.

In the locked configuration of FIG. 6, the portions of the suture tail12 defining the first opening 24 and the second opening 26 are drawntogether, thereby causing the suture tail 12 to assume the lockedconfiguration of FIG. 6, in which the locking member 28 has a generallyhorseshoe-shaped, u-shaped, or bunched, configuration. In the lockedconfiguration of FIG. 6, the locking member 28 restricts the suture tail12 from passing back through the first adjustable suture loop 50, whichprevents the suture construct 14 from loosening its hold of the tissue104 against the bone 102.

As illustrated in FIG. 6, upon tensioning the second adjustable sutureloop 52 onto the tissue 104, the anchor 30 is forced upward against theundersurface 112 of the bone 102. This force causes the anchor 30 todeform to the collapsed, balled, or squished position of FIG. 6, whichfurther retains the anchor 30 within the bone. Although the otherfigures herein do not specifically illustrate the anchor 30 within thisconfiguration, further tensioning of the second adjustable suture loop52 such that the anchor 30 is forced against the undersurface 112 of thebone 102 will cause the anchors 30 to assume the position of FIG. 6.

With continued reference to FIG. 6, excess portion 88 of the sutureconstruct 14 pulled through the second body 56 at the second end 60 ofthe suture construct 14 can be cut and removed. The excess portion 90 ofthe suture tail 12 beyond the locking member 28 can be cut and removedas well. While the method for securing the tissue 104 to the bone 102described above includes implanting the anchor 30 within the bone 102before passing the suture tail 12 around the tissue 104, the suture tail12 can be passed around the tissue before the anchor 30 is implanted inthe bone 102.

With additional reference to FIGS. 7A and 7B, use of the knotless sutureanchor device 10 to secure a separated rotator cuff tissue 120 to ahumerus 122 is illustrated. As illustrated, the device 10 includes asecond anchor 70 attached to the suture tail 12 in addition to theanchor 30, which is also referred to herein as a first anchor 30. Thesecond anchor 70 is substantially identical to, or the same as, thefirst anchor 30. The second anchor 70 can be attached to the suture tail12 in any suitable manner, such as by using the suture anchor reloadassembly disclosed in FIGS. 17-21 of the '304 Application, which isincorporated herein by reference as set forth above. The second anchor70 is attached to the suture tail 12 between the first end 16 of thesuture tail 12 and the first anchor 30. The knotless suture anchordevice 10 can be used to fasten any suitable portion of the tissue 120to the humerus 122. For example, the device 10 can be arranged to extendin the medial to lateral direction, or to extend in the anterior toposterior direction.

With particular reference to FIG. 7A, the first anchor 30 is firstimplanted in a first bone hole 124A formed in the humerus 122 andarranged such that the first anchor 30 is secured within a cancellousbone layer 126 due to contact with an undersurface 128 of cortical bonelayer 130. The first anchor 30 can be implanted in any suitable manner,such as by using the inserter 150 the '304 Application, or any of theinserters described herein. The first anchor 30 is inserted through therotator cuff tissue 120 such that both the first portion 66 of thesuture tail 12 and the second portion 68 of the suture tail 12 extendthrough the rotator cuff tissue 120.

The second anchor 70 can be implanted in the humerus 122 in a secondbone hole 124B in the same way that the first anchor 30 is implanted,such as by using the inserter disclosed in the '304 Application or anyof the inserters described herein. The second anchor 70 is implantedthrough the tissue 120, and thus the suture tail 12 extends through thetissue 120. Thus, as illustrated in FIG. 7A, the suture tail 12 extendsthrough the tissue 120 twice at the first anchor 30 (first in throughthe tissue 120 to the first anchor 30 and then back out through thetissue 120 from the first anchor 30) and twice at the second anchor 70(first in through the tissue 120 to the second anchor 70 and then backout through the tissue 120 from the second anchor 70).

With additional reference to FIG. 7B, the rotator cuff tissue 120 istightened against the humerus 122 and secured thereto by inserting thefirst end 16 of the suture tail 12 through the first adjustable sutureloop 50 of the suture construct 14, and pulling the suture tail 12completely through the first and the second anchors 30 and 70, similarto that which is illustrated in FIGS. 4 and 5. As a result, the sutureconstruct 14 is carried through and extends through both the firstanchor 30 and the second anchor 70, as illustrated in FIG. 7C.

With continued reference to FIG. 7C, the first adjustable suture loop 50is coupled to the second adjustable suture loop 52 at an outer surface132 of the tissue 120. Pulling the second end 60 of the suture construct14 tightens the suture construct 14 against the tissue 120 to hold aninner surface 134 of the tissue 120 against the humerus 122. Pulling thesecond end 60 also allows a surgeon to tension the tissue 120 againstthe humerus 122. In this arrangement, the suture construct 14 is thusimplanted such that it overlaps the outer surface 132 of tissue 120between the first anchor 30 and the second anchor 70, which permitsfastening and tensioning of the tissue 120 to the humerus 122 over alarge area. While two anchors 30 and 70 are illustrated, any suitablenumber of anchors can be added to the suture tail 12, as described inthe '304 Application for example, and implanted in a similar fashion tofasten a larger area of the tissue 120 to the humerus 122.

Although the tissue 120 is illustrated as one complete piece of tissue120 in FIGS. 7A-7C, the knotless suture anchor device 10 can be used tocouple, secure, and retain two separated (i.e., torn) portions of thetissue 120 together. For example and with reference to FIG. 7C, theknotless suture anchor device 10 can be arranged such that the first andthe second anchors 30 and 70 are implanted on opposites of a tear in thetissue 120. Tightening the knotless suture anchor device 10 by pullingon the second end 60 as described above, will pull the two torn piecestogether to facilitate healing.

With additional reference to FIGS. 8A and 8B, another method forsecuring the rotator cuff tissue 120 to the humerus 122 will now bedescribed. As illustrated, bone hole 124 is formed in the humerus 122laterally offset from an edge 136 of the tissue 120. The first portion66 of the suture tail 12 is passed through the tissue 120 such that thefirst end 16 is first inserted into the inner surface 134 and then ispushed or pulled out from the outer surface 132, as illustrated in FIG.8B. The anchor 30 is implanted in the bone hole 124 either before orafter the first portion 66 of the suture tail 12 is passed through thetissue 120. After the anchor 30 is implanted, the first end 16 of thesuture tail 12 is inserted through the first adjustable suture loop 50(FIG. 8B), the suture construct 14 is pulled and carried through theanchor 30 (FIG. 8C), and the suture construct 14 is tightened to securethe tissue 120 to the humerus 122 (FIG. 8D). As illustrated in FIGS. 8Cand 8D, pulling the suture construct 14 through the anchor 30 andtightening the suture construct 14 pulls and stretches the tissue 120 inthe medial to lateral direction. The suture construct 14 is tightenedand the tissue 120 is tensioned by pulling the second end 60 of thesuture construct 14. Excess portions 88 of the suture construct 14 andexcess portions 90 of the suture tail 12 can then be cut and removed.

With reference to FIG. 9, another way in which the rotator cuff tissue120 can be secured to the humerus 122 is illustrated. The anchor 30 isimplanted in the bone hole 124 formed either under the tissue 120 orlaterally offset therefrom. The first end 16 of the suture tail 12 isthen passed through the tissue 120 from the inner surface 134 to theouter surface 132, and then back through the tissue 120 through theouter surface 132 and out the inner surface 134. The first end 16 isinserted through the first adjustable suture loop 50 and the sutureconstruct 14 is pulled through the tissue 120 along the same path thatthat the suture tail 12 was inserted. The second end 60 of the sutureconstruct 14 is then pulled to tension the tissue 120 and secure thetissue 120 to the humerus 122.

An additional way to secure the tissue 120 to the humerus 122 isillustrated in FIG. 10. The configuration of FIG. 10 is similar to thatof FIG. 9, except that the suture tail 12 is passed through the tissue120 in the opposite direction. Specifically, the first end 16 of thesuture tail 12 is inserted into the tissue 120 at the outer surface 132,through the tissue 120 such that the first end 16 exits the tissue 120at the inner surface 134, back into the tissue 120 at the inner surface134, and out from within the tissue 120 at the outer surface 132. Thefirst end 16 of the suture tail 12 is then inserted through the firstadjustable suture loop 50 and the suture construct 14 is pulled throughthe tissue 120 along the path that the suture tail 12 was inserted. Thesuture construct 14 is tightened against the tissue 120, and the tissue120 is tensioned against the humerus 122, by pulling the second end 60of the suture construct 14.

FIGS. 11A-11E illustrates another way to use the knotless suture anchordevice 10 to secure the tissue 120 to the humerus 122. With initialreference to FIG. 11A, the first end 16 of the suture tail 12 is firstpassed through the tissue 120. The first end 16 is inserted into theouter surface 132 of the tissue 120, pushed or pulled through the tissue120, and then pulled out of the tissue 120 at the inner surface. Thefirst anchor 30 is added to the first portion 66 of the suture tail 12in any suitable manner, such as described in the '304 Application. Thefirst anchor 30 is implanted in the humerus 122 in any suitable mannerusing any suitable insertion device, such as those described herein orin the '304 Application. FIG. 11B illustrates the first anchor 30implanted in the humerus.

With additional reference to FIG. 11C, the first end 16 of the suturetail 12 is again inserted through the tissue 120. This time the firstend 16 is inserted into the tissue 120 at the inner surface 134 andpassed through the tissue 120 such that the suture rail 12 exits fromthe outer surface 132 of the tissue 120. With additional reference toFIG. 11D, the second anchor 70 is mounted to the first portion 66 of thesuture tail 12 between the first end 16 and the tissue 120 in anysuitable manner, such as described in the '304 Application. The secondanchor 70 is then implanted in the humerus 122. The suture tail 12 neednot be passed through the tissue 120 for the second time. Thus, thesuture tail 12 can extend from the first anchor 30 directly to thesecond anchor 70 without passing through the tissue 120 therebetween.

After the second anchor 70 is implanted, the first end 16 of the suturetail 12 is inserted through the first adjustable suture loop 50, and thesuture tail 12 is pulled entirely through both the first anchor 30 andthe second anchor 70 such that the suture construct 14 connects thetissue 120 to the first and the second anchors 30 and 70. The sutureconstruct 14 is tightened by pulling on the second end 60 of the sutureconstruct 14, which stretches and tensions the tissue 120 laterally. Tofurther secure the suture construct 14, the first adjustable suture loop50 can be slid away from the second body 56 to prevent the firstadjustable suture loop 50 from passing over the locking member 28. FIG.11E illustrates the suture construct 14 in its final position withexcess portions of the suture tail 12 and the second end 60 of thesuture construct 14 removed.

With additional reference to FIG. 12, the tissue 120 can be secured tothe humerus 122 with more than two anchors. FIG. 12 illustrates fiveanchors, but any suitable number of anchors can be used. The anchors canbe implanted in most any suitable arrangement. For example, anchors 30,72, and 76 can be arranged medially and generally in alignment in theanterior to posterior direction. Anchors 70 and 74 can be arrangedlaterally and also aligned in the anterior to posterior direction. Thesecond adjustable suture loop 52 can be connected to the anchors 30, 70,72, 74, and 76 in any suitable pattern and configuration. For example,and as illustrated in FIG. 12, the second adjustable suture loop 52 canbe arranged in an overlapping configuration in which the secondadjustable suture loop 52 overlaps the outer surface 132 between each ofthe anchors 30, 70, 72, 74, and 76. The second adjustable suture loop 52is threaded through the tissue 120 and secured thereto in the samemanner described above with respect to the other ways in which theknotless suture anchor device 10 can be used to fasten the tissue 120 tothe bone 102.

With additional reference to FIGS. 13A-13D, the knotless suture anchordevice 10 can be used to secure two pieces of separated tissue togetherwithout anchoring the tissue to bone. Because the tissue is not anchoredto bone, the device 10 does not include an anchor, such as the firstanchor 30. Therefore, FIGS. 13A-13D the knotless suture anchor device 10does not include an anchor at all.

With initial reference to 13A, a first tissue portion 140A and a secondtissue portion 140B are illustrated. The first and second tissueportions 140A and 140B are separated to define a space therebetween. Thefirst tissue portion 140A includes an outer surface 142A and an innersurface 144A that is opposite to the outer surface 142A. Similarly, thesecond tissue portion 140B includes an outer surface 142B and an innersurface 144B that is opposite to the outer surface 142B.

To secure the first and the second tissue portions 140A and 140Btogether, the first end 16 of the suture tail 12 is inserted into theinner surface 144A of the first tissue portion 140A, passed through thefirst tissue portion 140A, and pulled out from within the first tissueportion 140A at the outer surface 142A. From the outer surface 142A, thefirst end 16 is pulled across the space between the first and the secondtissue portions 140A and 140B and passed through the second tissueportion 140B. The suture tail 12 enters the second tissue portion 140Bat the outer surface 142B and exits the second tissue portion 140B atthe inner surface 144B. The suture tail 12 is pulled entirely throughboth the first and second tissue portions 140A and 140B and passedthrough the first adjustable suture loop 50. Passing the suture tail 12entirely through the first and the second tissue portions 140A and 140Bcarries the suture construct through the first and the second tissueportions 140A and 140B and connects the suture construct 14 to the firstand the second tissue portions 140A and 140B, as illustrated in FIG.13B. The second adjustable suture loop 52 is tightened by pulling on thesecond end 60, which draws the first tissue portion 140A and the secondtissue portion 140B together. To lock the first adjustable suture loop50 onto the second adjustable suture loop 52, the first body 54 ispushed away from the second body 56 to close the first adjustable sutureloop 50. This procedure is faster, stronger, and more readily produciblethan tying a knot. As illustrated in FIG. 13D, locking member 28 furthersecures the first adjustable suture loop 50 onto the second adjustablesuture loop 52.

With additional reference to FIG. 14, an insertion device according tothe present teachings is illustrated at reference numeral 202. Theinsertion device 202 generally includes a handle 204 and a rod or shaft206 that extends from the handle 204. The handle 204 includes a proximalend 208 and a distal end 210. At an end of the rod 206 opposite to thehandle 204 is a tip 212.

With additional reference to FIG. 15, the insertion device 202 includesa suture retention assembly 214. The suture retention assembly 214generally includes an anchor 216 and a passing device 218. The anchor216 includes a first locking tab 220A and a second locking tab 220B atopposite sides of the anchor 216. Each of the first and the secondlocking tabs 220A and 220B are pivotable to permit the anchor 216 to beclipped onto the handle 204 and removed from the handle 204. Between thefirst and the second locking tabs 220A and 220B is a passing deviceretention member 222, which includes a first flange 224A and a secondflange 224B on opposite sides thereof. The passing device retentionmember 222 further defines a first recess 226A and a second recess 226Bon opposite sides of the passing device retention member 222. Extendingfrom an undersurface of the anchor 216 opposite to the passing deviceretention member 222 is a first projection 228A and a second projection228B. The first and second projections 228A and 228B are substantiallysimilar to one another and face one another. They are both flexible, andbiased to be compressed inward toward one another. Together, the firstand the second projections 228A and 228B define a rim 230 at a distalend thereof. As further described herein, the rim 230 is configured forthe first adjustable suture loop 50 to be secured thereto.

The passing device 218 includes a first clip 232A and a second clip 232Bextending from opposite sides of an elongated grip 234. Between thefirst clip 232A and the second clip 232B is a post 236 with a ring 238extending therefrom. The ring 238 can be made out of any suitablematerial having any suitable configuration that will suitable retain thesuture tail 12 within the ring 238 when passed therethrough. Forexample, the ring 238 can be a flexible Nitinol™ ring. As furtherdescribed herein, the passing device 218 is coupled with the anchor 216such that the post 236 is seated between the first projection 228A andthe second projection 228B to extend the first and the secondprojections 228A and 228B outward. The passing device 218 is alsopositioned such that the ring 238 extends beyond the rim 230. Thepassing device 218 is coupled to the anchor 216 in a first positionthrough cooperation between the first clip 232A and the first recess226A, and between the second clip 232B and the second recess 226B. Thegrip 234 can be moved to a second position by pulling on the grip 234such that the first clip 232A abuts the first flange 224A and the secondclip 232B abuts the second flange 224B. In the second position, the ring238 is retracted into the first and the second projections 238A and238B, and the post 236 is not between the first and the secondprojections 228A and 228B, thereby allowing the first and the secondprojections 228A and 228B to return to their contracted position, whichwill release the first adjustable suture loop 50 from the rim 230. Asdescribed further herein, when the suture tail 12 is inserted within thering 238 and the grip 234 is moved from the first position to the secondposition, the suture tail 12 is pulled through the first adjustablesuture loop 50.

With continued reference to FIG. 15, the suture retention assembly 214is coupled to the handle 204 at recess 240, which is about equidistantbetween the proximal end 208 and the distal end 210. The first and thesecond locking tabs 220A and 220B extend over the flange 242 to couplethe first and the second locking tabs 220A and 220B to the handle 204.When the suture retention assembly 214 is coupled to the handle 204, thegrip 234 of the passing device 218 is seated within grip cutout 244 ofthe handle 204. To decouple the suture retention assembly 214 from thehandle 204, the first and the second locking tabs 220A and 220B arepressed inward toward the passing device retention member 222, whichcauses the first and the second locking tabs 220A and 220B to disengagethe flange 242.

With additional reference to FIG. 16, connection of the knotless sutureanchor device 10 to the insertion device 202 will now be described. Theknotless suture anchor device 10 is mounted to the insertion device 202such that the anchor 30 is at the tip 212 between two prongs of a forkedportion 246. From the anchor 30, the first portion 66 of the suture tail12 extends to the handle 204 and is seated under the grip 234 in thegrip cutout 244. The suture construct 14 is also seated in the gripcutout underneath the grip 234. The first adjustable suture loop 50 isseated on the rim 230 such that the first and the second projections228A and 228B extend through the first adjustable suture loop 50. Thesecond end 60 of the suture construct 14 is also seated in the gripcutout 244 underneath the grip 234. The second end 60 extends towardsthe proximal end 208 of the handle 204 and at its tip can extend outfrom underneath the grip 234. The second end 60 can be fixedly securedto the suture retention assembly 214 to facilitate passage of the firstend 16 through the first adjustable suture loop 50, as further describedherein.

With additional reference to FIGS. 17A and 17B, a cross-sectional viewof the suture retention assembly 214 is illustrated. FIG. 17Aillustrates the suture retention assembly 214 coupled to the handle 204.The suture retention assembly 214 is in the first position and thesuture tail 12 is arranged such that it extends through the ring 238.With reference to FIG. 17B, the suture retention assembly 214 isillustrated decoupled from the handle 204 and the grip 234 is pulledoutward to place the suture retention assembly 214 in the secondposition such that the first and the second clips 232A and 232B areseated against the first flange 224A and the second flange 224Brespectively. In the second position, the post 236 and ring 238 pull thesuture tail 12 into the first adjustable suture loop 50. The post 236also no longer biases the first and the second projections 228A and 228Boutward, thereby allowing the first and the second projections 228A and228B to return to their biased inward positions and facilitate releaseof the first adjustable suture loop 50 from the rim 230.

With reference to FIGS. 18-23, use of the insertion device 202 to securethe tissue 104 to the bone 102 with the knotless suture anchor device 10will now be described. The insertion device 202 can also be used toimplant the knotless suture anchor device 10 to any other bone to secureany other type of tissue, such as a labrum as further described herein.The bone hole 110 can be formed in the bone 102 in any suitable mannerusing any suitable devices. Exemplary methods and device for forming thebone hole 110 are described in the '962 Application, which isincorporated herein by reference.

With initial reference to FIG. 18, with the knotless suture anchordevice 10 mounted thereto, the insertion device 202 is aligned above thebone hole 110 and inserted into the bone hole 110 to implant the firstanchor 30 in the inner cancellous bone layer 108 against theundersurface 112 of the outer cortical bone layer 106. With reference toFIG. 19, after the anchor 30 is positioned in the bone 102, the sutureretention assembly 214 is disconnected from the handle 204. As thesuture retention assembly 214 is disconnected, the first end 16 of thesuture tail 12 is released from being clamped within the grip cutout244, as is the suture construct 14. The first adjustable suture loop 50remains coupled to the rim 230 of the first and the second projections228A and 228B.

As illustrated in FIG. 20, the first portion 66 of the suture tail 12 isinserted through the ring 238 of the grip 234. The grip 234 is thenmoved from the first position to the second position in which the ring238 is pulled in between the first and the second projections 228A and228B to pull the first end 16 of the suture tail 12 into the firstadjustable suture loop 50. As the post 236 of the grip 234 is pulled outfrom between the first and the second projections 228A and 228B, thefirst and the second projections 228A and 228B contract to facilitaterelease of the first adjustable suture loop 50 from the rim 230. As aresult and as illustrated in FIG. 21, the suture tail 12 is threadedthrough the first adjustable suture loop 50, which decouples from therim 230. The suture construct 14 remains connected to the sutureretention assembly 214 by way of attachment of the second end 60 of thesuture construct 14 to the suture retention assembly 214.

With additional reference to FIGS. 22 and 23, the suture tail 12 ispulled entirely through the anchor 30, thereby drawing the secondadjustable suture loop 52 connected thereto into and through theinternal passage 40 of the anchor 30. As a result, the suture construct14 connects the tissue 104 to the anchor 30. Prior to tightening thesecond adjustable suture loop 52 to the tissue 104, the suture construct14 can by adjusted about the tissue 102 by sliding the second adjustablesuture loop 52 through the internal passage 40 of the anchor 30 becausethe internal passage 40 is dimensioned to permit the suture construct 14to slide therethrough. To tighten the suture construct 14 against thetissue 104 and adjust the tension of the suture construct 14, the secondend 60 of the suture construct 14 is pulled. Because the second end 60is still secured to the suture retention assembly 214, pulling of thesuture second end 60 can be facilitated by pulling on the grip 234 ofthe suture retention assembly. Once the suture construct 14 has beentensioned to a desired degree, excess portions 88 of the sutureconstruct extending from the second passage portion 64 can be removed.Excess portions 90 of the suture tail 12 can be removed any time afterthe suture tail 12 is pulled through the anchor 30 and the firstadjustable suture loop 50 is secured to the second adjustable sutureloop 52.

With additional reference to FIG. 24, the suture retention assembly 214can be modified to replace the ring 238 with a rod 248 defining a slot250. The slot 250 is configured to receive and retain the suture tail 12therein. The suture retention assembly 214 as illustrated in FIG. 24will work the same way as the suture retention assembly 214 illustratedin FIGS. 14-23.

With additional reference to FIGS. 25-27, an additional insertion deviceis illustrated at reference numeral 302. The insertion device 302generally includes a handle 304 and a rod 306 extending from the handle304. The handle 304 includes a proximal end 308 and a distal end 310.The rod 306 extends from the distal end 310 and terminates at a tip 312opposite to the distal end 310. The handle 304 defines a recess 314 thatextends from the distal end 310 to the proximal end 308. The recess 314also extends to a flange 316, which protrudes from the handle 304. A cap318 can be fastened to the flange 316.

As illustrated in FIG. 26, extending from the cap 318 is a post 320 thatdefines an annular recess 322 at a distal end thereof. The post 320 issized to be received within an aperture 324 of the handle 304. Theaperture 324 is aligned with the flange 316 such that when the cap 318is connected to the flange 316, the post extends through the aperture324 to an opposite side of the handle 304, as illustrated in FIG. 27.The flange 316 includes a first edge 326A and a second edge 326B that isopposite to the first edge 326A. The first and the second edges 326A and326B are spaced apart to define a gap therebetween. An end of the flange316 opposite to the aperture 324 includes a first tab 328A and a secondtab 328B.

The knotless suture anchor device 10 is mounted to the insertion devicesuch that the anchor 30 is seated between forked portions 330 of the tip312. Both the first portion 66 and the second portion 68 of the suturetail 12 extend from the anchor 30 to the handle 304 and are seatedwithin the recess 314 of the handle 304. The first portion 66 of thesuture tail 12 further extends through the aperture 324 and out of theflange 316, as illustrated in FIG. 27. When the cap 368 is connected tothe flange 316, the first portion 66 of the suture tail 12 is pinchedbetween the cap 318 and the flange 316 to retain the first portionproximate to the first end 16 at the flange 316. With further referenceto FIG. 27, the first adjustable suture loop 50 is seated within theannular recess 322 of the post 320.

Insertion device 302 is used to implant the anchor 30 in bone in thesame manner as that described above with respect to the insertion device202. After the anchor 30 has been implanted, the cap 318 is disconnectedfrom the flange 316 to release the first portion 66 of the suture tail12 from being coupled to the handle 304. As the post 320 is pulled outfrom within the aperture 324, the first adjustable suture loop 50 willcontact the handle 304 and be pushed out from within the annular recess322, thereby detaching the suture construct from the post 320 and fromthe handle 304. Once detached from the handle 304, the knotless sutureanchor device 10 can be freely used to secure a desired tissue to boneor two tissues together. For example, the anchor 30 can be implanted inthe bone hole 110 using any suitable flexible anchor insertion device.The suture tail 12 is then threaded through the first adjustable sutureloop 50 by hand, and the suture construct 14 is fastened to the desiredtissue as described above in connection with FIGS. 1A through 6.

With general reference to FIGS. 28-32 and initial reference to FIG. 28,another insertion device according to the present teachings isillustrated at reference numeral 350. The insertion device 350 includesa handle 352 with a proximal end 354 and a distal end 356 that isopposite to the proximal end 354. A rod 358 extends from the distal end356 of the handle 352. The rod 358 terminates opposite to the distal end356 of the handle 352 at a tip 360. The tip 360 includes a forkedportion 362 that provides a retention portion for the anchor 30, asfurther described herein.

The handle 352 further includes a slot 364 that extends from one side ofthe handle to the other. The slot 364 provides a passageway for theknotless suture anchor device 10 to extend to flange 366, as furtherdescribed herein. A cap 368 is configured to be releasably connected tothe flange 366, to retain the second end 60 of the suture construct 14connected to the handle 352, as further described herein. As illustratedin FIG. 29, the flange 366 includes a first flange edge 370A and asecond flange edge 370B that is spaced apart from the first flange edge370A to define a gap between the first and the second flange edges 370Aand 370B. The flange 366 further includes a first tab 372A and a secondtab 372B that are configured to cooperate with the cap 368 to secure thecap 368 to the flange 366.

The insertion device 350 further includes a pin 374. A slot 376 isdefined within the pin 374. Extending from the pin 374 is a post 378. Aloop 380 extends from the post 378. The pin 374 is removably connectedto the handle 352 in a transverse portion 364A of the slot.

With continued reference to FIGS. 28 and 29, arrangement of the knotlesssuture anchor device 10 when coupled to the insertion device 350 willnow be described. The device 10 is described for exemplary purposes onlyas any suitable retention device can be connected to the insertiondevice 350. The anchor 30 is positioned at the tip 360 between forks ofthe forked portion 362. The first portion 66 of the suture tail 12extends towards the handle 352 and is seated within the slot 376 of thepin 374, which is seated in the transverse portion 364A of the slot 364.The second portion 68 of the suture tail 12 extends from the anchor 30to the slot 364 and into the slot 364. The suture construct 14 connectedto the second portion 68 is arranged such that the first adjustablesuture loop 50 is seated within the transverse portion 364A of the slot364 and the second end 60 of the suture construct 14 extends up throughthe flange 366 and out of the flange 366. The cap 368 is coupled to theflange 366 over the suture construct 14 proximate to the second end 60to secure the suture construct 14 to the handle 352. The pin 374 isseated in the transverse portion 364A such that the post 378 extendsthrough the first adjustable suture loop 50 and the loop 380 is on aside of the first adjustable suture loop 50.

To further retain the knotless suture anchor device 10 to the handle352, the insertion device 350 can also include a retention strand 390.The retention strand 390 includes a first end 392 that is coupled toknob 394 of the handle 352. From the knob 394 the retention strand 390extends to the tip 360 of the rod 358 and overlaps the anchor 30. Fromthe anchor 30 the retention strand 390 extends into the slot 364 and tothe flange 366. The retention strand 390 extends out through the flangeand terminates at a second end 396 that is opposite to the first end392. The cap 368 is secured to the flange 366 over the retention strand390 to secure the portion of the retention strand 390 proximate to thesecond end 396 to the handle 352.

With additional references to FIGS. 30-32, operation of the insertiondevice 350 will now be described. After the anchor 30 has been insertedinto a hole formed in bone, the first portion 66 of the suture tail 12is removed from within the slot 376 of the pin 374. The first end 16 ofthe suture tail 12, which is included with the first portion 66, is theninserted or passed through the loop 380 of the pin 374. The suture tail12 is threaded through the first adjustable suture loop 50 bywithdrawing the pin 374 from within the transverse portion 364A of theslot 364 and from the handle 352 altogether, as illustrated in FIGS. 31and 32. To decouple the suture construct 14 from engagement with thehandle 352, the cap 368 is removed. With the cap 368 removed, both thesecond end 396 of the retention strand 390 and the suture construct 14can be decoupled from the handle 352 by pulling them out through theslot 364. The first end 392 of the retention strand 390 can be untiedfrom the knob 394 or be cut proximate to the knob 394. The sutureconstruct 14 can then be tightened as described above.

Use of the knotless suture anchor device 10 to repair torn labrum tissue402 of a glenoid cavity 404 will now be described with reference toFIGS. 33-38. Repair of the labrum tissue 402 is described for exemplarypurposes only because the knotless suture anchor device 10 can be usedto repair any suitable tissue, such as an acetabular labrum. Theknotless suture anchor device 10 is described as being mounted to theinsertion device 202 described above and illustrated in FIGS. 14-24, butany suitable insertion device can be used, such as the insertion devices302 and 350.

With initial reference to FIG. 33, a suture passer 406 with a suturepassing strand 408 mounted thereto is inserted through a first cannula410 underneath a torn portion of the labrum tissue 402. A grasper 412 isinserted through a second cannula 414. The grasper 412 is used to graspthe passing strand 408 and pull the passing strand 408 up from under thelabrum tissue 402. The passer 406 is removed and another grasper (notshown) is inserted through the first cannula 410 to grasp the passingstrand 408. The passing strand 408 is then pulled up through the firstcannula 410. The first cannula 410 is positioned anteroinferior and thesecond cannula 414 positioned anterosuperior. To drain any excess fluid,a fluid cannula 416 can be introduced into the glenoid cavity 404

Outside of the joint space, the passing strand 408 is tied to the firstportion 66 of the suture tail 12, which is detached from the insertiondevice 202 by unclipping the suture retention assembly 214 from thehandle 204, as illustrated in FIG. 19, for example. As illustrated inFIG. 34, the passing strand 408 is pulled out of the first cannula 410to draw the suture tail 12 into the glenoid cavity 404 and around thelabrum tissue 402. FIG. 35 illustrates the first portion 66 of thesuture tail 12 looped around the labrum tissue 402.

FIG. 35 also illustrates a drill guide 420, which includes teeth 420A ata distal end thereof configured to cut bone for example, insertedthrough the first cannula 410. The drill guide 420 is positionedsuperiorly to the suture tail 12 and a drill 422 is inserted therethoughto form a bone hole 424 in the glenoid cavity 404. The rod 206 of theinsertion device 202 is inserted through the first cannula 410 toimplant the anchor 30 within the bone hole 424, such as illustrated inFIG. 19 with respect to the anchor 30 being implanted in bone hole 110.Tension is maintained on the suture tail 12 by the surgeon as the anchor30 is implanted. The anchor 30 can be implanted by impaction, such as bystriking the distal end 210 of the handle 204 with a hammer. After theanchor is implanted, the rod 206 can be removed out from within thefirst cannula 410.

The suture tail 12 is then inserted through the first adjustable sutureloop 50 by inserting the first end 16 thereof through the ring 238 ofthe passing device 218, as illustrated in FIG. 20. As illustrated inFIG. 21, the passing device 218 is pulled outward from the anchor 216 toplace the suture retention assembly 214 in the second position. Thefirst adjustable suture loop 50 is thus released from cooperation withthe rim 230. The suture tail 12 is then pulled through the anchor 30 toadvance the suture construct 14 to the labrum tissue 402 and around thelabrum tissue 402, as illustrated in FIG. 37. The anchor 30 isunderneath, and obstructed by, the labrum tissue 402 in FIG. 37, andthus not specifically shown. The second end 60 of the suture construct14 extends out from the second cannula 414, and can be grasped by thesurgeon to tighten the suture construct 14 onto the labrum tissue 402 ata desired tension. FIG. 38 illustrates the suture construct 14 securedonto the labrum tissue 402 at its final position. Additional sutureconstructs 14A, 14B, and 140 can also be fastened to the labrum tissuein the same manner as described above to further secure the labrumtissue 402 to the glenoid cavity 404.

With reference to FIG. 39, an additional insertion device according tothe present teachings is illustrated at 502. The insertion device 502generally includes a handle 504 and a rod 506. The handle 504 includes aproximal end 508 and a distal end 510 opposite to the proximal end 508.The rod 506 extends from the distal end 510. The rod 506 includes a tip512 at a distal end thereof. The handle 504 defines a recess 514, anotch 516 at the distal end 510, and a guide 518 at the proximal end508. The recess 514 is sized and shaped to receive a suture retentionassembly or retention member 550 therein.

With additional reference to FIG. 40, the suture retention assembly 550includes a main body 552 and a plunger 554. The main body 552 includes afirst coupling member 556A and a second coupling member 556B. The mainbody 552 includes a handle 558 at a proximal end thereof. The main body552 defines a center bore 560 that extends through a length of the mainbody 552. The main body 552 defines an aperture 562 at a distal end,which is opposite to the handle 558. The aperture 562 provides anopening of the center bore 560. A support flange 564 extends axiallyoutward from the main body 552 and the aperture 562. The support flange564 defines a recess 566 therein, which is configured to receive thefirst adjustable suture loop 50 of the knotless suture anchor device 10,for example. The main body 552 is removably coupled to the handle 504through cooperation between the first and second coupling members 556Aand 556B, and retention ridge 568, which is defined by the handle 504 atthe recess 514.

The plunger 554 generally includes a proximal end 570 and a distal end572. The plunger 554 defines a center bore 574 that extends from thedistal end 572 towards the proximal end 570. The center bore 574 canextend towards the proximal end 570 to any suitable position between thedistal end 572 and the proximal end 570. At the proximal end 570 is anactuation pad 576, which can be grasped to facilitate movement of theplunger 554 relative to the main body 552. The plunger 554 is slidablyreceived within the center bore 560 of the main body 552 and retainedtherein with retention clip 578, which cooperates with an interiorsurface of the center bore 560.

The plunger 554 includes a distal portion 580 at the distal end 572. Aproximal portion 582 is spaced apart from the distal portion 580, and anintermediate portion 584 is between the distal portion 580 and theproximal portion 582. The intermediate portion 584 has a notch orsection removed therefrom to make it smaller in cross-section than eachof the distal portion 580 and the proximal portion 582. The distal andproximal portions 580 and 582 can have diameters of similar length, andoffset radii. A distal flange 586 is defined by the distal portion 580at an interface between the distal portion 580 and the intermediateportion 584. A proximal flange 588 is defined between the proximalportion 582 and the intermediate portion 584. The distal and proximalportions 580 and 582 can abut one another, and the intermediate portion584 need not be included.

A support loop 600, such as a flexible Nitinol™ loop or ring, isarranged within the center bore 574 and fixedly mounted to the main body552. As illustrated in FIG. 41, prior to actuation of the plunger 554the support loop 600 protrudes out from within the center bore 574 andbeyond the distal end 572.

The support flange 564 is generally flexible and is flexed to anoutwardly flexed position by the distal portion 580 when the distalportion 580 is positioned beneath the support flange 564, as illustratedin FIGS. 41 and 42 for example, in order to facilitate retention of thefirst adjustable loop 50 thereon. When the plunger 554 is actuated, thedistal portion 580 is moved out from adjacent the support flange 564.Since no surface of the plunger 554 is present under the support flange564 to maintain the support flange 564 in the outwardly flexed position,the support flange 564 is biased to flex inward. The support flange 564freely flexes inward as illustrated in FIG. 43 to facilitate release ofthe first adjustable loop 50 from the support flange 564.

With continued reference to FIGS. 39 and 40, and additional reference toFIG. 41, coupling of a suture construct, such as the suture construct 14of FIG. 1A, to the insertion device 502 will now be described. Thesuture construct 14 is arranged such that the anchor 30 is at andsupported by the tip 512 of the rod 506. The suture retention assembly550 is seated within the recess 514 and coupled to the handle 504through cooperation between the first and second coupling members 556Aand 556B and the retention ridges 568 of the handle 504. The suture tail12 is positioned between the suture retention assembly 550 and thehandle 504, and a portion of the suture tail 12 proximate to the firstend 16 extends through the handle 504. The first end 16 is arranged on aside of the handle 504 opposite to the suture retention assembly 550.The suture construct 14 is arranged such that it extends over theproximal end 508 of the handle 504 and is seated within the guide 518defined by the proximal end 508. The suture construct 14 continues tothe suture retention assembly 550 where the first adjustable suture loop50 is seated on the support flange 564 of the main body 552, and withinthe recess 566 defined by the support flange 564.

With additional reference to FIGS. 42 through 44, operation of thesuture retention assembly 550 will now be described. After the anchor 30has been inserted into a bone hole, the suture retention assembly 550 isseparated from the handle 504, as illustrated in FIG. 41. Separating thesuture retention assembly 550 releases the suture tail 12 from thehandle 504. The first end 16 of the suture tail 12 is passed through theloop 600, as illustrated in FIG. 42. With reference to FIG. 43, theplunger 554 is pushed inward such that a distal end 572 thereof passesover the loop 600 to position the loop 600 within the center bore 574 ofthe plunger 554, thereby trapping the suture tail 12 within the centerbore 574. Actuation of the plunger 554 also causes the proximal flange588 to contact the first adjustable suture loop 50 and push the firstadjustable suture loop 50 off of the support flange 564 and onto thesuture tail 12. With reference to FIG. 44, the suture tail 12 is thenpulled entirely through the first adjustable loop 50 by pulling thesuture retention assembly 550. The suture construct 14 can then betightened by pulling on the second end 60 as described above andillustrated in FIG. 6 for example, in order to secure tissue 104 to bone102, for example.

With additional reference to FIGS. 45-61, a method for forming aknotless suture anchor device according to the present teachings willnow be described. The reference numbers generally correspond to theknotless suture anchor device 10 described above and illustrated in, forexample, FIGS. 1A and 1B, and any differences between the knotlesssuture anchor device 10 and the device formed in FIGS. 45-61 will beexplained herein.

With initial reference to FIG. 45, the second portion 68 of the suturetail 12 is illustrated. The second portion 68 includes a first end 68Aand a second end 68B. Second end 18 of the suture tail 12 is at thesecond end 68B of the second portion 68. As illustrated in FIG. 46, athreader, such as the threader 92 or any suitable threading device, isinserted through a first area of the second portion 68 of the suturetail 12 to define a first tail sleeve 68C. The threader 92 is alsoinserted through a second area to define a second tail sleeve 68D. Thesecond tail sleeve 68D is closer to the first end 68A than the firsttail sleeve 68C.

With the threader 92 extending through each of the first tail sleeve 68Cand the second tail sleeve 68D, the first end 68A is inserted into thethreader 92 and grasped by the threader 92. The threader 92 is thenwithdrawn through the second tail sleeve 68D and the first tail sleeve68C in order to draw the first end 68A through the second tail sleeve68D and into the first tail sleeve 680, as illustrated in FIG. 47.Therefore, the second portion 68 defines a loop 68E. Again, since thetail 16 is made from braided fibers, the first tail sleeve 68C and thesecond tail sleeve 680 are formed by a passage formed by the braidedfibers that extends from the first end 66A to the second end 66B. Endsof each of the first tail sleeve 680 and the second tail sleeve 68D areformed by openings in the braided fibers.

With additional reference to FIG. 48, the first portion 66 of the suturetail 12 includes a first end 66A that is opposite to a second end 66B.The threader 92 is inserted through the first portion 66 at or proximateto the second end 66B to define a third tail sleeve 660 in the firstportion 66. The second end 68B of the second portion 68 is insertedthrough the threader 92, and the threader 92 is withdrawn through thethird tail sleeve 660 in order to draw the second portion 68 into thethird tail sleeve 660, as illustrated in FIG. 49.

With additional reference to FIG. 50, the first end 66A of the firstportion 66 is inserted through the loop 68E of the second portion 68,and the first end 66A is pulled, which pulls the third tail sleeve 66Cover and past the first tail sleeve 68C and onto the second tail sleeve680, as illustrated in FIG. 51. With additional reference to FIG. 52, anexcess area of the second portion 68 proximate to the first end 68A iscut from a remainder of the second portion 68. As illustrated in FIG.53, the first portion 66 and the second portion 68 are then pulled apartto strengthen the connection between the first portion 66 and the secondportion 68, and thereby form the suture tail 12 of the knotless sutureanchor device 10.

To make it easier for a surgeon to distinguish between the first portion66 and the second portion 68 of the suture tail 12, the first portion 66and the second portion 68 can be configured in any suitable manner tofacilitate distinction therebetween, such as visual distinctiontherebetween. For example, the first portion 66 and the second portion68 can include or consist of different colors, and/or different designpatterns. The first and second portions 66 and 68 can also havedifferent thicknesses or weights.

With additional reference to FIGS. 54-58, a suture 14′ for forming asuture construct 14A (see FIG. 61) is illustrated. The suture construct14A described below is similar to the suture construct 14 illustrated inFIGS. 1 and 1A, for example, but includes a first adjustable suture loop50A that is formed differently from the first adjustable suture loop 50of suture construct 14.

The suture 14′ includes a first end 58 and a second end 60, which isopposite to the first end 58. With reference to FIG. 55, the inserter 92is passed through the suture 14′ proximate to the first end 58 to definea first construct sleeve 14B therein. The second end 60 of the suture14′ is then passed through the threader 92, and the threader 92 iswithdrawn through the first construct sleeve 14B in order to pull thesecond end 60 of the suture 14′ through the first construct sleeve 14Bto form the first adjustable suture loop 50A, as illustrated in FIG. 56.With reference to FIG. 57, the first adjustable suture loop 50A isseated over a spacer 96, and both the first end 58 and the second end 60are pulled in order to tighten the first adjustable suture loop 50A,thereby making the first adjustable suture loop 50A smaller. Withfurther reference to FIG. 58, an excess portion of the first end 58extending outward from the first adjustable suture loop 50A can beremoved with any suitable cutting device.

With additional reference to FIG. 59, after the first adjustable sutureloop 50A is formed, the second end 60 is passed through the elongatedpassageway 22 at the suture tail sleeve portion 20, such as by using thethreader 92. With reference to FIG. 60, the second end 60 is then passedthrough a second construct sleeve 14C proximate to the first adjustablesuture loop 50A, such as with the threader 92, to form the secondadjustable suture loop 52. As illustrated in FIG. 61, a knot 98 isformed proximate to the second end 60 to prevent the second end 60 frompassing back through the second construct sleeve 140.

An anchor, such as soft anchor 30, may be passed onto the suture tail12. The soft anchor 30 may be arranged such that it covers both thethird tail sleeve 66C of the first portion 66 and the second tail sleeve68D of the second portion 68. As illustrated in FIG. 61, the soft anchor30 may be positioned such that the second end 66B of the first portion66 extends slightly out from within the soft anchor 30 to facilitateinsertion, such as when using one of the insertion tools 202, 302, 350,and 502 described herein. Having the third tail sleeve 660 positionedinside of the soft anchor 30 helps the soft anchor 30 stay open afterthe soft anchor 30 is set in bone. This allows passage of elongatedpassageway 22 through the anchor 30 at a lower load. Further, connectionthe first portion 66 and the second portion 68 inside the anchor 30 whenprovided with different colors permits color differentiation of thefirst and second portions 66 and 68 arthroscopically.

During a surgical procedure, after the suture construct 14A has beenarranged around or though tissue (such as tissue 104 of FIG. 6 to securethe tissue 106 to bone 102) and the tail 12 has been passed through thefirst adjustable suture loop 50A such that the second adjustable sutureloop 52 extends through the first adjustable suture loop 50A, the sutureconstruct 14A is tensioned by pulling on the second end 60 of the sutureconstruct 14A. Pulling on the second end 60 causes both the firstadjustable suture loop 50A and the second adjustable suture loop 52 tobecome smaller. With respect to the first adjustable suture loop 50A, itbecomes smaller as the suture 14′ is pulled further through the firstconstruct sleeve 14A, with the second adjustable suture loop 52extending through the first adjustable suture loop 50A to provide acounter force. The first adjustable suture loop 50A closes onto thesecond adjustable suture loop 52 seated therein to prevent the tail 12from passing back through the first adjustable suture loop 50A.

Although the insertion tools 202, 302, 350, and 502 are illustrated anddescribed above as including the anchor 30, the anchor need not beincluded. For example, any of the insertion tools 202, 302, 350, and 502can be used to insert the suture tail 12 and suture construct 14 throughthe first tissue portion 140A and the second tissue portion 140B tomerge the first and the second tissue portions 140A and 140B together,which does not involve use of the anchor 30.

As described above, the suture constructs 14 and 14A allow a firsttissue to be coupled to a second tissue without the need to tie knots,which makes surgery, particularly arthroscopic procedures, easier andfaster. In some instances, by eliminating the need to tie knots thesuture constructs 14 and 14A may make the connection between first andsecond tissues more reliable. The suture tail 10 facilitates passing thesuture construct through or around tissue, particularly duringarthroscopic procedures. The suture tail 10 may be passed through oraround the tissue before or after the anchor 30 has been implanted,which can further expedite and make arthroscopic procedures lesscomplicated.

What is claimed is:
 1. A method for forming a flexible member forcoupling tissue, the method comprising: forming a first loop of aself-locking construct of the flexible member by passing a second end ofthe construct through a first sleeve defined by the self-lockingconstruct proximate to a first end of the self-locking construct;forming a second loop of the self-locking construct of the flexiblemember by passing the second end of the self-locking construct through asecond sleeve defined proximate to an end of a flexible tail, therebycoupling the self-locking construct to the tail, and then passing thesecond end through a third sleeve defined by the self-locking constructproximate to the first loop; wherein the self-locking construct isconfigured such that passing the tail through the first loop so that thesecond loop extends into the first loop and forms a tissue captureregion defined by the self-locking construct; and wherein the flexibletail defines a locking member at the second sleeve that is configured tosecure the second loop to the first loop.
 2. The method of claim 1,further including: forming the flexible tail, including: coupling afirst tail portion to a second tail portion.
 3. The method of claim 1,further including: forming the flexible tail, including: passing a firstend of a first tail portion through a fourth sleeve defined proximate tothe first end of the first tail portion to define a loop in the firsttail portion; passing a second end of the first tail portion through afifth sleeve defined proximate to a first end of a second tail portion;passing a second end of the second tail portion through the loop in thefirst tail portion; and pulling the fifth sleeve of the second tailportion over the fourth sleeve of the first tail portion to secure thefirst tail portion to the second tail portion and form the flexibletail.
 4. The method of claim 1, further including: forming the flexibletail, including: coupling a first tail portion including a first colorto a second tail portion including a second color that is different fromthe first color.
 5. The method of claim 1, further including: formingthe flexible tail, including: coupling a first tail portion including afirst design pattern to a second tail portion including a second designpattern that is different from the first design pattern.
 6. The methodof claim 1, further including: forming the flexible tail, including:coupling a first tail portion including a first thickness to a secondtail portion including a second thickness that is different from thefirst thickness.
 7. The method of claim 1, further including: formingthe flexible tail, including: coupling a first tail portion including afirst weight to a second tail portion including a second weight that isdifferent from the first weight.
 8. The method of claim 1, furtherincluding: arranging a soft anchor on the tail.
 9. A method for forminga flexible member for coupling tissue, the method comprising: forming aself-locking construct including a first loop and a second loop, whereinforming the first loop of the self-locking construct includes passing asecond end of the self-locking construct through a first sleeve definedby the self-locking construct proximate to a first end of theself-locking construct; forming a flexible tail including coupling afirst tail portion to a second tail portion; and coupling theself-locking construct to the flexible tail to form the flexible member,wherein a portion of the second loop extends through a portion of theflexible tail, wherein coupling the first tail portion to the second taiportion includes: passing a first end of a first tail portion through asecond sleeve defined proximate to the first end of the first tail todefine a third loop in the first tail portion; passing a second end ofthe first tail portion through a third sleeve in the second tailportion; passing a second end of the second tail portion through thethird loop in the first tail portion; and pulling the third sleeve ofthe second tail portion over the second sleeve of the first tail portionto secure the first tail portion to the second tail portion and form theflexible tail.
 10. The method of claim 9, wherein forming the secondloop of the self-locking construct includes: passing the second end ofthe self-locking construct through a fourth sleeve defined proximate toan end of a flexible tail, thereby coupling the self-locking constructto the flexible tail, and then passing the second end through a fifthsleeve defined by the self-locking construct proximate to the firstloop.
 11. The method of claim 10, further including: arranging a softanchor on the flexible tail.
 12. The method of claim 11, wherein thesoft anchor is arranged such that the soft anchor covers the secondsleeve of the first tail portion and the third sleeve of the second tailportion.
 13. The method of claim 11, wherein the soft anchor is arrangedon the flexible tail such that the soft anchor covers the second sleeveof the first tail portion and a first portion of the third sleeve of thesecond tail portion such that as second portion of the third sleeveextends out from within the anchor.